Job title: Director of Process Development Location: Limerick Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As a Process Development Director you will lead the design, optimization, and scale-up of manufacturing processes for biosynthetic, medical device products.
This R drive design for manufacturability and design-to-cost initiatives Plan and manage technology transfer activities from development to production lines, including support in process validation (IQ/OQ/PQ), commissioning, and start-up support Partner with Formulation, Technical Operations, Manufacturing, and Quality teams to select equipment, automation, and process technologies; evaluate capital project needs and contribute to / manage budget planning Experience required: Bachelor's degree in Chemical Engineering or a closely related field with an advanced degree (MS/PhD) preferred 10+ years of experience in process development, process scale-up, and manufacturing transfer in medical devices or similarly regulated industries (e.g., pharma, biotech) with hands-on leadership responsibilities Deep knowledge of GMP/ISO ***** quality systems, CAPA, change control, document control, and regulatory expectations for medical devices Proven expertise in process characterization, design of experiments (DOE), statistical analysis, and robust process validation (IQ/OQ/PQ) Strong background in one or more of the following process areas common to medical devices: polymer processing, lyophilization, polymer milling, coloration, and sterilization, with a bias toward reliable, scalable polymer manufacture Demonstrated success in technology transfer from development to manufacturing to meet commercial demand Excellent project management, planning, and budget management skills; ability to manage multiple programs concurrently Travel: occasional travel to sites, vendors, and customers as needed (typical expectation: light to moderate travel).
Role is EU based, with a possible need to relocate to the manufacturing location with Collaborative mindset with the ability to build strong partnerships across R